3D-printed versus conventional Hyrax expanders to widen the upper jaw in adolescents
Three-dimensionally Printed Hyrax Versus Conventional Hyrax for Maxillary Arch Expansion in Adolescents: A Randomized Controlled Trial
This compares a 3D-printed Hyrax expander with a conventional Hyrax to see which widens the upper jaw better in adolescents with maxillary transverse deficiency.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 22 (estimated) |
| Ages | 12 Years to 17 Years |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Trial ID | NCT07411092 on ClinicalTrials.gov |
What this trial studies
Adolescents with a narrow upper jaw will receive either a conventionally fabricated Hyrax expander or a custom 3D-printed Hyrax. Treatment effects on both dental and skeletal structures will be measured before and after expansion using cone-beam CT (CBCT) scans and digital dental models. The study focuses on precision, customization, and the amount and pattern of maxillary expansion across patients aged 12–17 with CVMS 3–5. Results aim to inform clinicians about differences in outcomes and fit between the two appliance types.
Who should consider this trial
Good fit: Ideal candidates are cooperative adolescents aged 12–17 with skeletal maxillary transverse deficiency (with or without crossbite) at cervical vertebral maturation stages 3–5 who can attend follow-up visits.
Not a fit: Patients with prior orthodontic treatment, craniofacial syndromes or clefts, a vertical growth pattern, poor oral hygiene or active periodontal disease, or those who are unable to attend follow-ups are unlikely to benefit from this trial.
Why it matters
Potential benefit: If successful, a 3D-printed Hyrax could offer more precise, better-fitting expansion with improved comfort and predictable skeletal changes compared with conventional devices.
How similar studies have performed: Digital and 3D-printed orthodontic appliances have shown technical promise in laboratory and design reports, but there is currently no clinical evidence directly comparing 3D-printed and conventional Hyrax expanders.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged between 12 to 17 years. 2. Skeletal age ranges from CVMS 3 to CVMS 5. 3. Skeletal maxillary transverse deficiency with/without crossbite. 4. Cooperative and able to attend follow-up visits. Exclusion Criteria: 1. Previous orthodontic treatment. 2. Craniofacial syndromes, or cleft lip and/or palate. 3. Patients with vertical growth pattern. 4. Very bad oral hygiene and active periodontal disease. 5. Vulnerable groups such as individuals with cognitive impairments or intellectual disabilities and individuals with severe mental health disorders.
Where this trial is running
Cairo, Cairo Governorate
- Faculty of dentistry, Ain Shams univeristy — Cairo, Cairo Governorate, Egypt (Recruiting)
Study contacts
- Study coordinator: Sara S Mandour, Msc, Assistant lecturer
- Email: sarasaleh@dent.asu.edu.eg
- Phone: +201061531431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.